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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Titan Reverse Shoulder System

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  Class 2 Device Recall Integra Titan Reverse Shoulder System see related information
Date Initiated by Firm October 24, 2014
Date Posted November 08, 2014
Recall Status1 Terminated 3 on July 21, 2015
Recall Number Z-0197-2015
Recall Event ID 69596
510(K)Number K100448  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees.

The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder System. It is used to project the osteotomy angle on the humeral head.
Code Information Lot Numbers PM0278 and PM0277
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact David E. Gronostajski
609-275-0500
Manufacturer Reason
for Recall		 A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly. Specifically, the threaded handle has been welded backwards on the template resulting in the cutting angle being the reverse of what it should be.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm will notify their consignees via letter delivered by traceable courier service. The consignee will be asked to complete and return a form to the recalling firm stating if they have affected product or not.
Quantity in Commerce 12 units
Distribution Nationwide Distribution including the states of TX, CA, OH, MS, VA, IL, TN, GA, CA, FL, and AZ.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWS and Original Applicant = ASCENSION ORTHOPEDICS, INC.
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